National Registry of Cardioneuroablation in Recurrent Reflex Syncope (CANVAS-R)

University Hospital of Bordeaux

Status

Enrolling

Conditions

Bradycardia

Syncope, Vasovagal

Heart Arrest

Treatments

Procedure: Cardioneuroablation

Study type

Observational

Funder types

Other

Identifiers

NCT06159764

CHUBX 2022/62

Details and patient eligibility

About

This registry aims to collect patient data on cardioneuroablation for vasovagal syncope from multiple centers in France. The aim is to evaluate success rates, compare techniques and help institutions set up their own cardioneuroablation program

Full description

Cardioneuroablation is an emerging technique used to treat patients with vagally-mediated extrinsic bradycardia. It seems particularly efficient in patients with recurrent vasovagal syncope due to a strong cardioinhibitory effect. The procedure consists in using radiofrequency ablation to destroy cardiac ganglionated plexi located in epicardial fat pads around the atrias. Key questions concerning this procedure still remain unanswered: 1) What is the success rate of the procedure 2) Which patients will benefit from this technique? 3) Which fat pads should be targeted during the procedure? 4) What is the best way of identifying the location of these fat pads? 5) What are the long-term effects of this procedure? A multicenter registry seems ideal to try to answer these questions at minimal cost

Enrollment

50 estimated patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients aged 18 or more
Recurrent vasovagal syncope (≥2 episodes during the last year) with an asystolic component (≥3 second pause) recorded during a spontaneous episode. The asystole can be related to sinus arrest or paroxysmal AV block.
Scheduled cardioneuroablation procedure
Estimated residual battery life ≥ 1 year.
Patient affiliated to or beneficiary of national health security scheme.
Patient who have received an information notice and has not objected to the use of their data in the registry.

Exclusion criteria

Contraindication to anticoagulation therapy: major bleeding, risk of major bleeding, severe hepatic disease
Contraindication to cardiac CT: contrast medium allergies
Intracardiac thrombus
Patient detained by judicial or administrative decision.